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Diss Factsheets
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EC number: 217-915-8 | CAS number: 2008-39-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions Impurities of the test substance are not reported
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the genotoxicity of 2,4-dichlorophenoxyacetic acid and its derivatives in mammalian cell cultures
- Author:
- Gollapudi, B.B., Charles, J.M., Linscombe, V.A., Day, S.J., Bus, J.S.
- Year:
- 1 999
- Bibliographic source:
- Mutation Research, 444, 217-225
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The assay was conducted by methods described by O'Neill and Hsie (1979) and O'Neill et al. (1977, 1982)
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 5742-17-6
- Cas Number:
- 5742-17-6
- IUPAC Name:
- 5742-17-6
- Reference substance name:
- isopropylamine 2,4-dichlorophenoxyacetate
- IUPAC Name:
- isopropylamine 2,4-dichlorophenoxyacetate
- Reference substance name:
- 2,4-D, isopropylamine salt
- IUPAC Name:
- 2,4-D, isopropylamine salt
- Details on test material:
- - Name of test material (as cited in study report): 2,4-D IPA
- Analytical purity: 50.15% of active ingredient
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- HGPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- used cells: CHO-K1-BH4
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix (Sprague-Dawley rat liver, Aroclor 1254- induced); final concentration in the treatment medium = 2% v/v
- Test concentrations with justification for top dose:
- 0, 500, 1000, 1500, 2000 and 3000 µg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO or distilled water
Final concentration of the solvent in the treatment medium: 1%
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 20-methylcholanthrene (4 µg/mL)
- Remarks:
- without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- with S9-mix
Migrated to IUCLID6: 621 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4-5 h
- Selection time (if incubation with a selection agent): 7-9 days
SELECTION AGENT (mutation assays): 6-thioguanine (10 µg/mL)
NUMBER OF CELLS EVALUATED: The frequency of mutants per 10 to the power of 6 clonable cells
DETERMINATION OF CYTOTOXICITY
- Cloning efficiency was estimated by plating 200 cells/60 mm plate (three plates/replicate).
The test material toxicity was assessed by determining the cloning efficiency of the cells at the end of the treatments and expressed relative to the negative controls (relative cell survival, RCS) - Evaluation criteria:
- The frequency of mutants per 10 to the power of 6 clonable cells was statistically evaluated using a weighted analysis of variance.
- Statistics:
- A linear trend test and lack of fit test was employed (α = 0.05) as an omnibus test to compare treated groups to the negative control. If there was a significant increasing trend or a significant lack of fit, a Dunnett's test was conducted, comparing each group and the positive control to the negative control (α = 0.05, one-sided). An additional comparison of the positive control to the negative control was conducted using a linear contrast statement.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- for the highest dose (3000 µg/mL) without activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results of CHO/HGPRT assay on 2,4-D IPA
Concentration (µg/mL) |
S9 (+/-) |
Assay 1 |
Assay 2 |
||
RCS (%) |
MF (x 10-6) |
RCS (%) |
MF (x 10-6) |
||
0 |
- |
98.6 |
1.5 |
95.4 |
0.9 |
|
- |
101.4 |
1.8 |
104.6 |
0.0 |
|
+ |
110.8 |
2.4 |
99.3 |
0.0 |
|
+ |
89.2 |
0.8 |
100.7 |
5.7 |
500 |
- |
100.1 |
2.7 |
128.3 |
1.4 |
|
- |
94.4 |
0.0 |
137.8 |
5.8 |
|
+ |
92.4 |
3.1 |
88.0 |
11.3 |
|
+ |
89.2 |
2.1 |
96.6 |
5.0 |
1000 |
- |
86.3 |
4.5 |
139.4 |
9.0 |
|
- |
102.9 |
4.4 |
134.5 |
9.1 |
|
+ |
90.0 |
4.5 |
81.2 |
5.3 |
|
+ |
97.2 |
6.9 |
78.2 |
5.3 |
1500 |
- |
86.3 |
3.7 |
125.5 |
5.5 |
|
- |
87.3 |
2.5 |
139.4 |
11.6 |
|
+ |
88.4 |
3.5 |
82.8 |
6.1 |
|
+ |
101.5 |
6.5 |
78.2 |
1.5 |
2000 |
- |
73.9 |
4.0 |
|
|
|
- |
73.1 |
2.2 |
97.5 |
10.1 |
|
+ |
106.0 |
4.9 |
82.8 |
6.7 |
|
+ |
90.6 |
9.7 |
|
|
3000 |
- |
46.9 |
6.2 |
36.6 |
* |
|
- |
43.2 |
0.0 |
40.6 |
14.7 |
|
+ |
64.8 |
7.3 |
61.7 |
13.2 |
|
+ |
68.8 |
3.6 |
20.0 |
3.6 |
PC |
- |
45.2 |
157.5 |
56.6 |
298.2 |
|
- |
35.4 |
264.5 |
55.1 |
350.9 |
|
+ |
75.7 |
90.3. |
100.7 |
113.0 |
|
+ |
66.9 |
106.9 |
86.8 |
127.9 |
RCS: relative cell survival following treatment;
MF: mutant frequency; PC: positive control
* culture lost due to impaired cell proliferation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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